SKAWINA, 00000, PL
Job details
Work flexibility: Hybrid
Req ID: R543075
Employee type:
Full Time
Temporary
Job category: RAQA
Travel: 10%
Relocation: No
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We are proud to offer you our total rewards package which includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards – not to mention various social and recreational activities, all of which are location specific.
We are proud to offer you our total rewards package which includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards – not to mention various social and recreational activities, all of which are location specific.
Job description
Senior Microbiology & Sterilization Specialist will be responsible of sterilization validations, cycles maintenance, sterilization cycle evaluation, product adoption and ensuring compliance to the applicable methods and regulatory standard requirements. Additionally, it will conduct proper training regarding of microbiology and sterilization. It is expected that Sterilization Control Assurer can act as a Subject Matter Expert for Microbiology and Sterilization topics.
What You Will Do
- Continuously fully complies with all regulatory and quality system requirements.
- Assure and enforce compliance to sterilization controls regulatory requirements as they relate to the production and release of sterile products. Provide critical analysis, decision making, and the origination of Position Statements for local and companywide deployment as needed in the following areas:
- – Sterilization Controls
- – EM Monitoring Program
- – Product Disposition
- Ensure that the appropriate documentation and procedures are established and reviewed as per latest regulatory requirements to assure compliance to the sterilization control sub-system and requirements set for the Environmental Controlled Areas.
- Effectively follow up to interactions of all control and monitoring processes/programs within the Sterilization Controls sub-system elements as defined above to assure product sterility.
- Effectively follow up to interactions of all control and monitoring processes/programs within the ECA to assure compliance to regulatory requirements.
- Effectively follow up on all documentation related to final product release.
- Ensure the appropriate educational tools and programs are in place to assure product sterility and disposition.
- Monitor the state of the Sterilization Controls sub-system, the Environmental Controlled Areas, Batch Record Review and Product Disposition through tracking and trending, monthly reports and product/system audits as applicable and identifying areas of opportunity and possibilities for growth.
- Ensures regulatory compliance by evaluating proposed changes as they relate to the Sterilization Controls requirements.
- In house mentor for Sterilization controls (per FDA-QSR, ISO, AAMI, etc) related topics.
- Conducts & documents sterilization controls, environmental controlled areas and Product disposition related investigations as needed
- Conducts Risk Assessments.
- Conducts & Reviews NC reports and CAPA Projects
- Participate in product quality trend analysis (Non Conformance Monitoring Board)
- Establishes (defines, documents, and implements) procedures for sterility assurance elements, environmental controlled areas and product disposition as needed.
- Establishes policies and practices related to behavior, control, and access to all Controlled Environment Areas.
- Employee has the necessary authority to execute above mentioned job responsibilities and will have authority to carry out specific responsibilities defined by quality system documents.
- Employee has authority to recommend and initiate preventive and corrective action with regard to product non-conformance’s and quality system activities as they relate to the Sterilization Controls sub-system elements, Environmental Controlled Areas and Product Disposition.
Who we are looking for
- 4+ years of experience in a microbiology & sterilization area, preferably in a medical manufacturing or pharmaceutical industry setting
- Familiarity with regulatory requirements and standards governing microbiological and sterilization testing in the medical device or pharmaceutical industry, including FDA regulations, USP, EP, and ISO standards.
- Experience with quality management systems (QMS), such as ISO 13485, ISO 17025
- Experience working with regulatory agencies, conducting regulatory submissions, and responding to regulatory inquiries or observations.
- Microbiology and sterility testing execution skills and high level proficiency in sterilization controls related matters.
- knowledge of statistical analysis techniques and software for data analysis (e.g., Minitab, JMP, etc.).
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology and Orthopaedics that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.
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